Gilead’s Biktarvy (Bictegravir, Emtricitabine and Tenofovir Alafenamide) Receives MHLW’s Approval for HIV-1 Infection in Japan

 Gilead’s Biktarvy (Bictegravir, Emtricitabine and Tenofovir Alafenamide) Receives MHLW’s Approval for HIV-1 Infection in Japan

Gilead’s Biktarvy (Bictegravir, Emtricitabine and Tenofovir Alafenamide) Receives MHLW’s Approval for HIV-1 Infection in Japan

Shots:

  • The approval is based on four P-III 1489 and 1490 & 1844 and 1878 studies result assessing Biktarvy vs PBO in 2,415 naive patients with HIV-1 infected & virologically suppressed adults respectively
  • The P-III 1489 and 1490 & 1844 and 1878 studies results: @48wks. met its 1EPs; no treatment emergent virologic resistance; no discontinuation; no cases of proximal renal tubulopathy/Fanconi syndrome; high barrier to resistance
  • Biktarvy (qd) is an INSTI-based triple-therapy STR combining bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg (BIC/FTC/TAF) and has a boxed warning for its discontinuation of post treatment acute exacerbation of Hepatitis B

Click here to read full press release/ article | Ref: Gilead | Image: Twitter

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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